Food and Drug Regulations

C.01A.006 (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment.

(1.1) An application to amend an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 that are to be carried out in respect of a category of drugs that is set out in Table II to that section and that includes a drug that is fabricated, sold or represented for use in relation to a condition described in the List of Conditions that Threaten Public Health, as defined in section C.08.001.1, may include a statement to that effect.

(2) An establishment licence must be amended where the licensee proposes

• (a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;

• (b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;

• (c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and

• (d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,

  • (i) to add a fabricator, packager/labeller or tester of a drug,

  • (ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and

  • (iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.